The Premier Consulting Blog

OCTOBER 1, 2023

It is the sixth reauthorization of PDUFA that provides the FDA with necessary resources and includes provisions to increase the efficiency of the drug development process. PDUFA VII will be in effect from fiscal year 2023 through fiscal year 2027.

FDA 52

FDA Packaging Drug Development Drugs 52

Agency IQ

MAY 17, 2024

How have pre-submission meetings for generic drug applicants changed under GDUFA III? Under GDUFA III, the scope and purpose of pre-submission meetings for generic drug developers has changed. The generic drug user fee program is currently on its third iteration (i.e., What to expect on the day of the meeting?

Science 40

Science FDA Production Drugs 40

Agency IQ

JULY 28, 2023

September 2023 Legislative deadlines in Q3 Legislation Program Tag Requirement Due Date FDORA, Section 3202 Orphan Drug Program FDA shall publish final guidance related to the draft guidance titled, “Rare Diseases: Common Issues in Drug Development.” But despite the law’s age, it is not yet fully operational.

FDA 40

FDA Science Biosimilars Regulations 40